Glycerine, a tableting additive, has been used for its ability to lend stickiness to tablet formulations. Some stickiness is desirable, serving to provide cohesion to hold the tablet ingredients together so that they are flowable and can be processed readily. However, in certain situations, the use of glycerine can produce too much stickiness, resulting in the formulations clumping or sticking in various machine parts before and during tableting. Self-binding, readily flowable compositions containing no glycerine have been unknown to the art.
One method for addressing the need for self-binding flowable formulations was the production of shearform matrices or flosses. These matrices result when using certain processing techniques, such as the following:
Matrices formed by flash-heat processing are known. U.S. Pat. No. 5,429,836, incorporated herein by reference, describes the flash flow process and its use to make amorphous solid shearform matrices having flake-like form.
U.S. Pat. No. 5,587,172, also incorporated herein by reference, discusses the use of flash heat techniques to produce sucrose-containing flosses, which are then processed to yield tablets.
The use of shearform matrices for forming comestible units is described in WO95/34290 (published Dec. 21, 1995) from co-assigned application No. PCT/US95/07144, filed Jun. 6, 1995. The PCT case discloses a quick dissolving tablet which is formed by: (1) using flash-flow technology to provide a shearform matrix; (2) combining the partially recrystallized matrix with an additive to form flowable, compactable particulate blends; and (3) compacting the blends at relatively low pressure to form comestible units, such as tablets.
Additionally, PCT publication WO 95/34293 (published Dec. 21, 1995) from co-assigned PCT Application No. PCT/US95/07194, filed Jun. 6, 1995, discloses a process and apparatus for making rapidly dissolving dosage units by flash-flow processing. In this PCT application, a shearform matrix is formed by the flash-flow process, the shearform matrix is combined with an additive, and the matrix is molded to make a unit dosage form. Tamping may be used to compact the dosage form and increase its integrity.